(57 days)
No
The device description and performance studies focus on standard centrifugal technology and optical readout, with no mention of AI, ML, or related concepts.
No
The device is a micro hematocrit centrifuge, used to measure hematocrit (a diagnostic measurement), not to treat or prevent a disease or condition.
Yes.
The device measures hematocrit, which is a key diagnostic indicator for various medical conditions, and comparative studies show its clinical utility is equivalent to a predicate diagnostic device.
No
The device description clearly outlines hardware components such as a centrifuge, battery charger, and physical safety features, indicating it is a physical medical device with potentially embedded software for the digital readout.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Measures Hematocrit: The device description explicitly states that it "Measures Hematocrit." Hematocrit is a measure of the volume percentage of red blood cells in blood, which is a diagnostic parameter.
- Uses Micro Capillary/Micro Capillary Holders (heparinized): This indicates that the device is designed to process blood samples, which is a key characteristic of IVD devices.
- Intended User / Care Setting: The intended users and settings (General Laboratory, Physician Office, Blood Bank) are typical environments where in vitro diagnostic testing is performed.
- Performance Studies: The document includes performance studies comparing the device to a predicate device and evaluating precision, which are standard requirements for demonstrating the performance of an IVD device.
- Predicate Device(s): The listed predicate devices (Compur MI100 Minicentrifuge, Compur Millo Hematocrit System) are also devices used for measuring hematocrit, further supporting the classification as an IVD.
While the "Intended Use / Indications for Use" section is listed as "Not Found" in the provided text, the other information strongly indicates that this device is intended for in vitro diagnostic use. It performs a measurement on a biological sample (blood) to provide information for diagnostic purposes (hematocrit).
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
o Micro Hematocrit Centrifuge
o Operations Manual
o Battery Charger
o 100 Micro Capillary/Micro Capillary Holders (heparinized)
The general features of the Spuncrit (Model DRC-40) as compared to the Compur M1100 Minicentrifuge.
o General Laboratory Device
o Methodology: Centrifugal
o Measures Hematocrit
o Battery Operated
o Portable, Hand-Held
Safety Features:
(1) Cover Lock
(2) Low Battery Charge Indicator
(3) Motor failure indicator
o Optically read (digital readout)
o Uses plastic disposable
o Range 14% to 57% ·
o Operates at 10,000 RPM
o RCF= 4260
o Rotor Radius= 1.5 inches
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General Laboratory, Physician Office, Alternate Site (Blood Bank)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Comparative data (Performance/Effectiveness Information) between the Spuncrit (Model DRC-40) and Compur's MILO Minicentrifuge.
An "In Service" to explain the operation of the Spuncrit was performed in each of the locations. Approximately 10 minutes were utilized for training of persons operating the Spunctic a nhe comparative study at each location included a total of 45 whole blood samples encompassing three levels ranging from below the normal range to the upper level of the normal range . The samples were split such that each location ran 15 samples at each level.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Study (Performance/Effectiveness Information)
Study Locations:
- Spuncrit operating in a Laboratory:
o Typical laboratory with technician running the Spuncrit
N = 45
Range = 14% Hot to 49% Hot
R = .99 - Spuncrit operating in Physician Office - #1
o Physician Office employs six Physicians with nurse running Spuncrit.
N = 45
Range = 14% Hot to 49% Hot
R = .99 - Spuncrit operating in Physician Office - #2
o Physician Office employs twelve physicians with a nurse running Spuncrit
N = 45
Range = 19% Het to 53% Hot
R = .99 - Spungrit operating in an Alternate Sitei
o Blood Bank with a Phlebotomist running the Spuncrit.
N = 45
Range = 14% Hot to 49% Hot
R = .99
Image /page/3/Figure/16 description: "Spuncrit vs Compur" and subtitled "Laboratory vs Laboratory". The graph shows a positive correlation between the two variables. The x-axis is labeled "Volat Spuncrit" and the y-axis is labeled "% Volat Compur". The data points on the graph are approximately (15, 15), (40, 60), and (50, 70).
Image /page/3/Figure/18 description: "Spuncrit vs Compur". The graph plots '% Hot Compur' on the y-axis and 'Site Spunart' on the x-axis. The graph shows a positive correlation between the two variables. The data points on the graph are approximately (10, 15), (40, 60), and (50, 75).
Image /page/3/Figure/20 description: "Spuncrit vs Compur", which compares Physician Office #2 (Spuncrit) vs Laboratory (Compur). The x-axis is labeled "% Hot Spuncrit" and the y-axis is labeled "% Hot Compur". A line is plotted on the graph, and the equation for the line is given as y = 0.7 + 0.96x.
Image /page/4/Figure/7 description: "Spuncrit vs Compur". The x-axis is labeled "%Hct Spuncrit" and ranges from 10 to 60. The y-axis is labeled "% Hct Compur" and ranges from 10 to 60. There is a line plotted on the graph that shows a positive correlation between the two variables.
Image /page/4/Figure/8 description: Each data point represents an average of 15 whole blood samples.
Precision Study
The precision study was performed within the physician office and another alternate site; a blood bank. Assayed whole blood controls were used in the precision study. Three levels of controls were used. A total of fifteen(15) samples were processed per each level for a total of 45 samples. The range varied from below the normal range to slightly above the normal range for the The study was repeated utilizing assayed whole blood hematocrit. controls from the same lot number seven (7) days after the first study.
Within Run Precision Data
PHYSICIAN OFFICE # 1
Day One (Hematocrit): Level 1 (X=18.1, SD=0.26, Cv=0.01, N=15), Level 2 (X=30.8, SD=0.94, Cv=0.03, N=15), Level 3 (X=46.3, SD=1.03, Cv=0.02, N=15)
Day Seven (Hematocrit): Level 1 (X=16.8, SD=0.77, Cv=0.04, N=15), Level 2 (X=32.4, SD=0.63, Cv=0.02, N=15), Level 3 (X=46.4, SD=0.63, Cv=0.02, N=15)
PHYSICIAN OFFICE # 2
Day One (Hematocrit): Level 1 (X=17.9, SD=0.70, Cv=0.04, N=15), Level 2 (X=33.5, SD=0.52, Cv=0.02, N=15), Level 3 (X=46.1, SD=0.74, Cv=0.02, N=15)
Day Seven (Hematocrit): Level 1 (X=17.4, SD=0.64, Cv=0.04, N=15), Level 2 (X=32.7, SD=0.59, Cv=0.02, N=15), Level 3 (X=47.7, SD=0.59, Cv=0.01, N=15)
ALTERNATE SITE (BLOOD BANK) # 3
Day One (Hematocrit): Level 1 (X=18.6, SD=0.51, Cv=0.03, N=15), Level 2 (X=33.7, SD=0.88, Cv=0.02, N=15), Level 3 (X=47.3, SD=1.11, Cv=0.02, N=15)
Day Seven (Hematocrit): Level 1 (X=18.8, SD=0.68, Cv=0.04, N=15), Level 2 (X=33.4, SD=0.51, Cv=0.02, N=15), Level 3 (X=47.5, SD=0.52, Cv=0.01, N=15)
Between Run Precision Data (Day One and Day 7 (Hematocrit))
Physician Office #1: Level 1 (X=17.4, SD=0.92, Cv=0.05, N=2), Level 2 (X=31.6, SD=1.13, Cv=0.04, N=2), Level 3 (X=46.4, SD=0.07, Cv=
§ 864.6400 Hematocrit measuring device.
(a)
Identification. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
0
174 57 196 16:16 MICRO DIAGNOSIICS
Image /page/0/Picture/1 description: The image shows a logo with the letters MDC in a bold, stylized font. The letters are large and take up most of the image. To the right of the letters, there is the word "Mic" in a smaller font. The logo appears to be for a company or organization with the initials MDC.
Image /page/0/Picture/2 description: The image shows a sequence of numbers and a letter, specifically 'K961803'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or drawn with a thick marker. The numbers and letter are evenly spaced and aligned horizontally.
Tics Cornorati
JUL - 5 1996
June 21, 1996
PAGE A
Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd Rockville MD 20850
K961803, Submission 510(k) Summary for Spuncrit™ RE:
Dear Sir or Madam:
A summary of the safety and effectiveness information upon which substantial equivalence is based as follows:
CLASSIFICATION :
Class II Hematocrit Centrifuge
PROPRIETARY NAME:
Spuncrit™ (Model DRC-40)
PRODUCTS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED:
o Compur MI100 Minicentrifuge FDA No. K850391 Date: May 10, 1985
SIMILARITIES TO PREDICATE DEVICES CURRENTLY ON THE US MARKET
A) Predicate's Name and Manufacturer Address
Hematocrit
o Compur Millo Hematocrit System Bayer Diagnostic + Electronic GmbH Steinerstrasse 15 8000 Muchen 70 Germany C/O Hans J. Brouwers and Associates Box 823 Mt Prospect, IL 60056 FDA Reference No. K850391
1
ﺮ
P.5715
PAGE B
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| A1) | Comparison of Spuncrit™ to Compur (Predicate Device) | |
|---|---|---|
| MICRO DIAGNOSTICS | ||
| SPUNCRIT™ | COMPUR | |
| M1100 | ||
| o Micro Hematocrit | ||
| Centrifuge | o Micro Hematocrit | |
| Centrifuge | ||
| o Operations Manual | o Operation Manual | |
| o Battery Charger | o Battery Replacement | |
| o 100 Micro Capillary/ | ||
| Micro Capillary | ||
| Holders (heparinized) | o 100 Capillaries | |
| (heparinized) | ||
| A2 ) | The general features of the Spuncrit™ (Model DRC-40) as | |
| compared to the Compur M1100 Minicentrifuge. | ||
| SPUNCRIT™ | COMPUR M1100 | |
| o General Laboratory | ||
| Device | o General Laboratory | |
| Device | ||
| o Methodology: | ||
| Centrifugal | o Methodology: | |
| Centrifugal | ||
| o Measures Hematocrit | o Measure Hematocrit | |
| o Battery Operated | o Battery Operated | |
| o Portable, Hand-Held | o Portable, Hand-held | |
| Safety Features: | Safety Features : | |
| (1) Cover Lock | (1) Cover Lock | |
| (2) | ||
| Low Battery Charge | ||
| Indicator | (2) | |
| Low Battery Charge | ||
| Indicator | ||
| (3) Motor failure indicator | (3) No such feature | |
| o Optically read | ||
| (digital readout) | o Manual, visual read |
2
| | 4
4 |
| -- | -------- |
|---|
o Uses plastic disposable
o Range 14% to 57% ·
o Operates at 10,000 RPM
o RCF= 4260
o Rotor Radius= 1.5 inches
- o Uses qlass disposable
o Range 10% to 80%
o Operates at 11,500 RPM
o RCF=5396
o Rotor Radius= 1.5 inches
The safety features of the Spuncrit™ as compared to the Compur A3) M1100 Minicentrifuge.
SPUNCE IT IN
COVER LOCK
Mechanical lock switch which prevents cover from being opened while centrifuge is in operation
MECHANICAL BRAKE
In the event the cover is opened prior to the Spuncrit completing the 150 second cycle time the rotor automatically is braked, stopping its rotation within a few seconds
LOW BATTERY CHARGE
Digital display reads out "C" indicating to operator to charge batteries
INSTRUMENT MALFUNCTION
In the event of an electronic failure within the instrument the digital readout will not display "8's", as the DRC-40 is running.
COMPUR M1100
COVER LOCK
Mechanical lock switch which prevents cover from being opened while centrifuge is in operation
MECHANICAL BRAKE
No such feature
LOW BATTERY CHARGE
An illuminated red LED indicates batteries need to be replaced
INSTRUMENT MALFUNCTION
No such feature
3
PAGE D
- Comparative data (Performance/Effectiveness Information) A4 } between the Spuncrit™ (Model DRC-40) and Compur's MILO Minicentrifuge.
RESULTS OBSERVED WHEN OPERATING THE SPUNCRIT
COMPARISON DATA
An "In Service" to explain the operation of the Spuncrit was performed in each of the locations. Approximately 10 minutes were utilized for training of persons operating the Spunctic a nhe comparative study at each location included a total of 45 whole blood samples encompassing three levels ranging from below the normal range to the upper level of the normal range . The samples were split such that each location ran 15 samples at each level.
Spunctit operating in a Laboratory:
- o Typical laboratory with technician running the Spuncrit
- N = 45 Range = 14% Hot to 49% Hot R = . 99
Spuncrit operating in Physician Office - #1
- o Physician Office employs six Physicians with nurse running Spuncrit.
- N = 45 Range = 14% Hot to 49% Hot R = . 99
Spuncrit operating in Physician Office - #2
- o Physician Office employs twelve physicians with a nurse running Spuncrit
N = 45 Range = 19% Het to 53% Hot R = . 99
Image /page/3/Figure/16 description: The image is a graph titled "Spuncrit vs Compur" and subtitled "Laboratory vs Laboratory". The graph shows a positive correlation between the two variables. The x-axis is labeled "Volat Spuncrit" and the y-axis is labeled "% Volat Compur". The data points on the graph are approximately (15, 15), (40, 60), and (50, 70).
Image /page/3/Figure/18 description: This image is a graph titled "Spuncrit vs Compur". The graph plots '% Hot Compur' on the y-axis and 'Site Spunart' on the x-axis. The graph shows a positive correlation between the two variables. The data points on the graph are approximately (10, 15), (40, 60), and (50, 75).
Image /page/3/Figure/20 description: The image shows a graph titled "Spuncrit vs Compur", which compares Physician Office #2 (Spuncrit) vs Laboratory (Compur). The x-axis is labeled "% Hot Spuncrit" and the y-axis is labeled "% Hot Compur". A line is plotted on the graph, and the equation for the line is given as y = 0.7 + 0.96x.
4
SBungrit operating in an Alternate Sitei
- o Blood Bank with a Phlebotomist running the Spuncrit.
N = 45
- Range = 14% Hot to 49% Hot R = . 99
Image /page/4/Figure/7 description: The image shows a graph titled "Spuncrit vs Compur". The x-axis is labeled "%Hct Spuncrit" and ranges from 10 to 60. The y-axis is labeled "% Hct Compur" and ranges from 10 to 60. There is a line plotted on the graph that shows a positive correlation between the two variables.
Image /page/4/Figure/8 description: The image contains text that describes the data points in a study. Each data point represents an average of 15 whole blood samples. This suggests that the data presented is based on a collection of blood samples, and each point is an average value calculated from those samples. This information is important for understanding the methodology and scope of the study.
5
inn 27 796 16:20 MICRO DIAGNOSTICS
PAGE P
PRECISION DATA
The precision study was performed within the physician office and another alternate site;a blood bank. Assayed whole blood controls were used in the precision study. Three levels of controls were used. A total of fifteen(15) samples were processed per each level for a total of 45 samples. The range varied from below the normal range to slightly above the normal range for the The study was repeated utilizing assayed whole blood hematocrit. controls from the same lot number seven (7) days after the first study .
WITHIN RUN PRECISION DATA
PHYSICIAN OFFICE # 1
Day One (Hematocrit)
Day Seven (Hematocrit)
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|---|---|
| 18.1 | 30.8 | 46.3 | X | 16.8 | 32.4 | 46.4 |
| .26 | .94 | 1.03 | SD | .77 | .63 | .63 |
| .01 | .03 | .02 | Cv | .04 | .02 | .02 |
| 15 | 15 | 15 | N | 15 | 15 | 15 |
PHYSICIAN OFFICE # 2
Day One (Hematocrit)
Day One (Hematocrit)
Day Seven (Hematocrit)
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|---|---|
| 17.9 | 33.5 | 46.1 | X | 17.4 | 32.7 | 47.7 |
| .70 | .52 | .74 | SD | .64 | .59 | .59 |
| .04 | .02 | .02 | Cv | .04 | .02 | .01 |
| 15 | 15 | 15 | N | 15 | 15 | 15 |
ALTERNATE SITE (BLOOD BANK) # 3
Day Seven (Hematocrit)
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|---|---|
| 18.6 | 33.7 | 47.3 | X | 18.8 | 33.4 | 47.5 |
| .51 | .88 | 1.11 | SD | .68 | .51 | .52 |
| .03 | .02 | .02 | Cv | .04 | .02 | .01 |
| 15 | 15 | 15 | N | 15 | 15 | 15 |
6
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P.10/15
| PAGE G | |||||
|---|---|---|---|---|---|
| BETWEEN RUN PRECISION DATA | |||||
| Day One and Day 7 (Hematocrit) | |||||
| Physician Office #1 | $\overline{X}$ | SD | Cv | N | |
| Level 1 | 17.4 | .92 | .05 | 2 | |
| Level 2 | 31.6 | 1.13 | .04 | 2 | |
| Level 3 | 46.4 | .07 |